Application 020178

Type: NDA
Sponsor: BAXTER HLTHCARE

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	900MG/100ML	Yes	Yes
002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	INJECTABLE;INJECTION	9MG/ML	Yes	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07
N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	SODIUM CHLORIDE	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
N020178-001	AP
N020178-002	AP

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	SOLUTION / INJECTION	AP	RLD, RS	1992-12-07	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	450MG/50ML (9MG/ML)	SOLUTION / INJECTION	AP	RLD	1992-12-07	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1992-12-07	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1992-12-07	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1992-12-07	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1992-12-07	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020178-001	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	900MG/100ML	INJECTABLE / INJECTION	AP	RLD, RS	1992-12-07	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020178-002	SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	9MG/ML	INJECTABLE / INJECTION	AP	RLD	1992-12-07	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020178-001	AP	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N020178-002	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020178-001	AP	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020178-002	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020178-001	AP	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020178-002	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020178-001	AP	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020178-002	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020178-001	AP	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020178-002	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020178-001	AP	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020178-002	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020178-001	AP	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020178-002	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020178-001	AP	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020178-002	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020178-001	AP	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020178-002	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020178-001	AP	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020178-002	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020178-001	AP	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020178-002	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020178-001	AP	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020178-002	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020178-001	AP	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020178-002	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020178-001	AP	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020178-002	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020178-001	AP	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020178-002	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020178-001	AP	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020178-002	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020178-001	AP	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020178-002	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020178-001	AP	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020178-002	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020178-001	AP	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020178-002	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020178-001	AP	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020178-002	AP	1	`bb7c543d1eb4…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	9e72418a-376e-4637-99ad-d13c904a7986	2025-07-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020178 application number: NDA020178
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	2fae04e3-20b1-4b8c-b1fb-646b384836f1	2022-12-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020178 application number: NDA020178 ndc (product): 0338-0192 ndc (product): 0338-0196 ndc (product): 0338-0186 ndc (product): 0338-0182
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	123bd10a-90c7-499e-97f6-acf7e0f0fb4e	2022-07-29	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020178 application number: NDA020178 ndc (product): 0338-0166 ndc (product): 0338-0164 ndc (product): 0338-0162 ndc (product): 0338-0160
SODIUM CHLORIDE	SODIUM CHLORIDE	Baxter Healthcare Corporation	aeaed9cb-b629-4019-88d2-a916179427de	2021-02-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020178 application number: NDA020178 ndc (product): 0338-9151 ndc (product): 0338-9159
Sodium Chloride	SODIUM CHLORIDE	Baxter Healthcare Corporation	fbc01464-8885-4075-af41-911ffec5ae92	2020-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020178 application number: NDA020178 ndc (product): 0338-0553

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 27 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0338-0160	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0162	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0164	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0166	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-0182	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0186	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0192	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0196	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-0553	Sodium Chloride	Sodium Chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9151	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current
0338-9159	SODIUM CHLORIDE	sodium chloride	Baxter Healthcare Corporation	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
72823	SUPPL	2022-12-08
61765	SUPPL	2020-02-04
58968	SUPPL	2019-06-04
58893	SUPPL	2019-05-30
34341	SUPPL	2015-11-25
21257	SUPPL	2015-11-24